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Natural Product Number (NPN):

80125612

Market status:

Not Marketed

Licence Status:

Active

Brand name(s):

Nicotine Lozenge 2mg Fast Dissolving ;
AddictAid Lozenge 2 mg Fast Dissolving

Licence holder:

CellChem Pharmaceuticals Inc.

Dosage Form:

Lozenge

Recommended route of administration:

Buccal

Recommended use or purpose:

Nicotine Lozenge can help you stop smoking by reducing withdrawal symptoms. Using Nicotine Lozenge can enable you to reduce the daily number of cigarettes smoked to ease the transition into a smoke-free lifestyle. Although smoking cessation is preferable, the product can also be used in cases when you need to temporarily refrain from smoking, for example, in smoke-free areas, airplanes, etc. or in other situations when you wish to avoid smoking.

Risk Information:

Cautions and Warnings 

Do not use if you: Are under 18 years of age. Are an occasional or non-smoker. Are pregnant or nursing. If you think you may be pregnant, stop using at once and see your doctor. Avoid becoming pregnant while using Nicotine Lozenge 2mg. Do not smoke or use other nicotine containing products using Nicotine Lozenge 2mg. Consult your doctor if you have difficulty in reducing the quantity of pieces used within three months. In the case of overdose or if a child consumes one or more pieces of Nicotine Lozenge 2mg contact your local doctor or poison control center at once even if there are no symptoms. Young children and pets are especially sensitive to the effects of even small doses of nicotine. Avoid drinking acidic beverages (coffee, tea, soft drinks, alcohol, citric juices) while using the lozenges as they may interfere with product effectiveness. Consult your dentist or doctor if injury or irritation to the mouth, teeth or gum around dentures occurs. Keep out of the reach of children and pets.

Contra-Indications 

Ask your doctor before use if you: Have/have had heart, thyroid, circulation, stomach, throat or mouth problems, high blood pressure or stroke; take insulin or any prescription medicine; have experienced seizures.

Known Adverse Reactions 

Nicotine Lozenge 2mg can cause side effects such as: feeling sick, mouth or throat soreness, upset stomach and other stomach problems, hiccups, constipation, dry mouth, headache, light-headedness, insomnia, cough. Stop using Nicotine Lozenge 2mg and seek medical advice if: Irregular heart beat, chest pain or leg pain occurs or if severe or persistent stomach upset (indigestion, heart burn) develops. Stop using Nicotine Lozenge 2mg if you develop symptoms of overdose such as nausea, abdominal pain, vomiting, diarrhea, cold sweat, dizziness, disturbed hearing and vision, mental confusion, marked weakness, rapid heart beat or difficulty breathing. Stop using Nicotine Lozenge 2mg if you develop severe allergic symptoms of which include sudden wheeziness or tightness of chest, rash and feeling faint. Common side effects of quitting smoking may include: irritability, trouble sleeping, increased appetite and headaches.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
3-(1-Methyl-2-pyrrolidinyl)pyridine	2.0 mg

List of non-medicinal ingredients:

• Aspartame
• Magnesium stearate
• Mannitol
• Mint flavour
• Sodium bicarbonate
• Sucrose
• Xanthan Gum

Date of licensing:

2023-07-17

Revised date of licence: